The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.
Study Type
OBSERVATIONAL
Enrollment
416
Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.
Primary Effectiveness Endpoint
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.
Time frame: 6 months
Primary Safety Endpoint
Observed device and/or procedure-related serious adverse events through 36 months.
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stanford University
Stanford, California, United States
Pelvic Solutions Center
Denver, Colorado, United States
Urology Specialists, LLC
Hialeah, Florida, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Boston Urogynecology Associates
Cambridge, Massachusetts, United States
Baystate Health System
Springfield, Massachusetts, United States
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, United States
Adult and Pediatric Urology & Urogynecology
Omaha, Nebraska, United States
University of Nevada
Las Vegas, Nevada, United States
...and 17 more locations